Evaluation of the Zilver Vascular Stent in the Iliac Arteries (ZIPS)

Cook Group

Status and phase

Completed

Phase 2

Conditions

Peripheral Arterial Disease (PAD)

Treatments

Device: Peripheral Vessel Stenting

Study type

Interventional

Funder types

Industry

Identifiers

NCT00196066

02-513

Details and patient eligibility

About

The purpose of this study is to assess the ability of a vascular stent to maintain an open iliac (leg) artery. The Zilver Vascular Stent is made of nitinol, a flexible metal with a long history of use in medical devices. The stent self-expands once inside the artery where it is intended to hold the vessel wall open. Within a few weeks, a layer of cells will grow over the stent helping to hold it in place.

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient has documented stenotic or occluded atherosclerotic lesions of the external iliac or common iliac artery.
Patient has a de novo or restenotic lesion(s) with no prior stent in the target lesion.
Patient has given informed consent.

Exclusion criteria

Patient is less than 50 years of age
Patient is participating in another investigational drug or device study.
Patient has multiple lesions (ipsilateral or in the aorta) that would require a staged procedure.
Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
Patient has a known hypersensitivity or contraindication to aspirin, clopidogrel, nitinol, or contrast dye that cannot be adequately premedicated.
Patient is pregnant or breast-feeding.